| Customization: | Available |
|---|---|
| CAS No.: | 1115-70-4 |
| Formula: | C4h12cln5 |
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| Item | Specification | Results | |
| Appearance | White or almost white crystals | White crystals | |
| Identification | B:IR-spectrum | Consistent with the spectrum of metformin-hydrochloride CRS. (2.2.24) | Complies |
| E:reaction of chlorides | It gives reaction of chlorides. (2.3.1) | Complies | |
| Appearance of solution | Clear(2.2.1)and colorless(2.2.2 Method II) | Clear and colorless | |
| Related substances | Cyanoguanidine(imp.A) ≤0.02% (2.2.29) | 0.0005% | |
| Any other impurity ≤ 0.05% (2.2.29) | 0.004% | ||
| Total impurities ≤ 0.2% (2.2.29) | 0.02% | ||
| Impurity F ≤ 0.05% (2.2.29) | 0.002% | ||
| Heavy metals | ≤ 10ppm (2.4.8) | < 10ppm | |
| Loss on drying | ≤ 0.5% (2.2.32) | 0.06% | |
| Sulphated ash | ≤ 0.1% (2.4.14) | 0.03% | |
| Assay % on dry basis | 98.5%-101.0% (2.2.20) | 100.0% | |
| Conclusion | The test results conform to the standard of EP. | ||
The End |
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